BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MMI/GAELTEC CATHETER TIP TRANSDUC

    K Number: K801756 · Decision Aug 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    23

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    Basic Information

    Device Name
    MMI/GAELTEC CATHETER TIP TRANSDUC
    K Number
    K801756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 20, 1980
    Product Code
    DXO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXO Transducer, Pressure, Catheter Tip

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    Other Clearances by Medical Measurements, Inc.

    K Number Device Name
    K921062 GAELTEC MPR SERIES
    K902097 MODEL TR RECTAL SUCTION BIOPSY TUBE
    K863479 MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
    K801757 MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
    K801880 MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
    K801758 MMI/GAELTEC CATHETER INTRAUTERINE
    K801755 MMI/GAELTEC CATHETER TIP PRESSURE